The harmonized standard EN ISO 14971 itself is not sufficient to be in compliance with regulatory requirements for risk management.
A variety of legal and normative requirements reference risk management and describe internal and external interfaces in the risk management process.
The PROSYSTEM supports you to identify and implement the product and country-specific requirements for risk management, such as:

  • IEC 62366/60601-1-6
  • IEC 62304/82304
  • IEC 60601/61010
  • IEC 80001-1 / FDA Guideline “Cyber Security“
  • ISO 10993
  • ISO/TR 24971
  • IEC/TR 80002-1
  • ISO/IEC Guide 63